Allergy treatment method using a rapid immunotherapy protocol

ABSTRACT

A method of treating a patient sensitive to an allergen includes a desensitizing rapid immunotherapy protocol of administering to the patient a series of gradually increasing doses of a composition comprising the allergen at intervals of about 15 minutes for a duration of less than about 120 minutes, and preferably less than about 90 minutes. A pretreatment protocol administers to the patient a therapeutically effective amount of at least one composition that is effective in reducing a sensitivity of the patient to an asthma associated allergenic reaction.

CONTINUING DATA

[0001] This application is a continuation of U.S. application Ser. No.09/644,719 filed on Aug.23, 2000, the disclosure of which is hereinexplicitly incorporated by reference.

BACKGROUND OF THE INVENTION 1. Field of the invention.

[0002] The present invention relates to a treatment protocol foradministering rapid immunotherapy, and, more particularly, to a methodof treating a patient having an immediate hypersensitivity to anallergen using an accelerated rapid immunotherapy schedule, incombination with a method of pretreating such patient prior to receivingthe accelerated immunotherapy.

[0003] 2. Description of the related art.

[0004] Conventional immunotherapy has been found generally effective inthe treatment of allergic rhinitis, allergic asthma, chronic sinusitis,and associated headaches. However, disadvantages include poorcompliance, delayed efficacy, and patient frustration. Various medicalpractices have therefore turned their attention towards the use of rushimmunotherapy or rapid desensitization because it offers the potentialof rapid response, improved compliance, and cost effectiveness.

[0005] However, the use in rush immunotherapy of higher antigen dosagelevels at accelerated injection schedule intervals is a significantconsideration in terms of its impact or responsibility in causingsystemic reactions in the patient.

[0006] In typical desensitization treatment, it is typically necessaryfor the patient to have injections very frequently, e.g., initiallyevery two or three days, gradually reducing to once every two or threeweeks. This is not only a time-consuming and inconvenient procedure thatposes an obstacle to full compliance, but is also very complex due tothe need to carefully monitor and control the administered dose ofallergen. The potential for allergic reactions such as hives, asthma,and, in some extreme cases, anaphylactic shock, makes desensitizationdifficult to successfully implement.

SUMMARY OF THE INVENTION

[0007] According to the present invention, there is provided a method oftreating a patient having an immediate hypersensitivity to allergens ofthe type that may produce systemic responses such as anaphylactic shockreactions. In accordance with the treatment method, a therapeuticallyeffective desensitizing amount of the allergen is administered to thepatient according to a rush or rapid immunotherapy protocol having anaccelerated schedule. In one form, the treatment protocol involvesadministering to the patient gradually increasing doses of the allergenat selected time intervals over a duration of less than about 120minutes, resulting in a treatment method that when combined with asubsequent observation period lasts less than half a day.

[0008] In a preferred form, the allergen is administered at fifteenminute intervals according to a dosing schedule that involves a sequenceof six injections effective in advancing the allergic patient to animmunizing or maintenance dose of allergen. For example, such dosingschedule may consist of 0.025 cc of a 1:100,000 allergen dilution, 0.25cc of a 1:100,000 dilution, 0.025 cc of a 1:10,000 dilution, 0.25 cc ofa 1:10,000 dilution, 0.025 cc of a 1:1000 dilution, and 0.25 cc of a1:1000 dilution. In this application, the ratios and volumes may bealtered as may come to be known in the art and still stay within thescope of the invention. Alterations of the ratio and volume dosage maybe varied in view of patient needs, allergen sensitivity, and allergenmanufacturing and availability.

[0009] According to another aspect of the present invention, there isprovided a method for pretreating the patient prior to receiving theforegoing rapid immunotherapy treatment protocol. According to themethod, a pretreatment protocol is performed which involvesadministering to the patient prednisone (or any other suitablecorticosteroid) and at least one of an H₁ histamine antagonist and/or anH₂ histamine antagonist. The H₁ histamine antagonist may be selectedfrom the group consisting of Claritin™, Seldane™, Zyrtec™, and Allegra™,or other similar medication while the H₂ histamine antagonist may beselected from the group consisting of Zantac™, Pepcid™, and Tagamet™, orother similar medication. Such similar medication may be generic formsof the groups or other similar physiological active compounds.

[0010] In a preferred form, this premedication regimen is combined withthe administration of a therapeutically effective amount of at least onecomposition which is effective in reducing a sensitivity of the patientto an asthma associated allergenic reaction or simply an allergenicreaction. For example, to control the sensitivity of the patient to anasthma-related allergen, the patient may be administered an inhaledcorticosteroid and/or the drug Singular™, which is a trade name of thegeneric drug leukotriene.

[0011] The invention, in one form thereof, is directed to a method oftreating a patient sensitive to an allergen or allergens, comprisingadministering to the patient a therapeutically effective desensitizingamount of a composition comprising the allergen or allergens over aduration of less than about 120 minutes. The treatment method ispreferably conducted according to a rapid immunotherapy protocol.

[0012] The method, in a preferred form, further includes a pretreatmentprotocol of administering to the patient prednisone and at least one ofan H1 histamine antagonist and/or an H₂ histamine antagonist. The H1histamine antagonist is preferably selected from the group consisting ofClaritin™, Seldane™, Zyrtec™, and Allegra™, while the H₂ histamineantagonist is preferably selected from the group consisting of Zantac™,Pepcid™, and Tagamet™. Other equivalent physiological active substitutesmay be substituted into the H₁, and H₂ groups.

[0013] The pretreatment protocol further includes administering to thepatient a therapeutically effective amount of at least one compositioneffective in reducing a sensitivity of the patient to an asthmaassociated allergenic reaction. For example, the patient may beadministered at least one of a corticosteroid (oral or inhaled) and aLeukotriene antagonist such as Singular™, Accolade™, or Zyflo™.

[0014] According to the rush immunotherapy, rapid desensitization, orrapid allergen vaccination protocol of the treatment method, theadministration of the allergen amount further comprises administering tothe patient at selected intervals gradually increasing doses of theallergen. In a preferred form, each selected interval is about fifteenminutes.

[0015] In a more preferred form, the intervaled administration ofallergen occurs in accordance with a dosing schedule consistingessentially of: (i) about 0.025 cc of about a 1:100,000 allergendilution, (ii) about 0.25 cc of about a 1:100,000 dilution, (iii) about0.025 cc of about a 1:10,000 dilution, (iv) about 0.25 cc of about a1:10,000 dilution, (v) about 0.025 cc of about a 1:1000 dilution, and(vi) about 0.25 cc of about a 1:1000 dilution.

[0016] The invention, in another form thereof, is directed to a methodof treating a patient sensitive to an allergen, comprising a protocol ofadministering to the patient a series of gradually increasing doses of acomposition comprising the allergen at selected intervals for a durationof less than about 120 minutes.

[0017] In a preferred form, each selected interval is about fifteenminutes. Additionally, the dilution level of allergen within each dosageis preferably within the range from between about 1:150,000 to about1:50,000 to between about 1:1500 to about 1:500. The amount of theallergen composition administered to the patient is therapeuticallyeffective in desensitizing the patient against the allergen.

[0018] The method, in a preferred form, further includes a pretreatmentprotocol of administering to the patient prednisone and at least one ofan H₁ histamine antagonist and/or an H₂ histamine antagonist.Additionally, the pretreatment protocol further includes administeringto the patient a therapeutically effective amount of at least onecomposition effective in reducing a sensitivity of the patient to anasthma associated allergenic reaction. For example, the patient may beadministered at least one of a cortisalsteroid and the drug Singular™.

[0019] The invention, in another form thereof, is directed to a methodof treating a patient sensitive to an allergen, comprising a protocol ofadministering to the patient a series of gradually increasing doses of acomposition comprising the allergen at intervals of about 15 minutes fora duration of less than about 120 minutes, and, more preferably, lessthan about 90 minutes.

[0020] In a preferred form, the dilution level of allergen within eachdosage is within the range from between about 1:150,000 to about1:50,000 to between about 1:1500 to about 1:500. More specifically, theprotocol is preferably defined by a dosing schedule consistingessentially of: (i) about 0.025cc of about a 1:100,000 allergendilution, (ii) about 0.25 cc of about a 1:100,000 dilution, (iii) about0.025 cc of about a 1:10,000 dilution, (iv) about 0.25 cc of about a1:10,000 dilution, (v) about 0.025 cc of about a 1:1000 dilution, and(vi) about 0.25 cc of about a 1:1000 dilution.

[0021] The method, in a preferred form, further includes a pretreatmentprotocol of administering to the patient prednisone and at least one ofan H₁ histamine antagonist and/or an H₂ histamine antagonist.Additionally, the pretreatment protocol further includes administeringto the patient a therapeutically effective amount of at least onecomposition effective in reducing a sensitivity of the patient to anasthma associated allergenic reaction. For example, the patient may beadministered at least one of a corticosteroid (oral or inhaled) and aLeukotriene antagonist such as Singular™, Accolade™, Zyflo™, otherzafirlukusts, or other montelukasts.

[0022] The invention, in another form thereof, encompasses the methodfor the treatment of an allergic condition by means of desensitizationtherapy by administering to a subject gradually increasing doses of acausative agent, wherein the improvement comprises such administrationof the causative agent at intervals of between about 10 to 20 minutesfor a duration of less than about 120 minutes, using at each interval adosage of the causative agent within the range of from between about1:150,000 to about 1:50,000 to between about 1:1500 to about 1:500.

[0023] The invention, in yet another form thereof, is directed to amethod of pretreating a patient prior to receiving desensitizing rapidimmunotherapy. The pretreatment method comprises, in combination, thesteps of administering to the patient prednisone and at least one of anH₁ istamine antagonist and an H₂ histamine antagonist, and administeringto the patient a therapeutically effective amount of at least onecomposition effective in reducing the sensitivity of the patient to anasthma associated allergenic reaction occurrable during and/or afterreception of the desensitizing rapid immunotherapy.

[0024] In a preferred form, the at least one composition which isadministered to reduce the sensitivity of the patient to an asthmaassociated allergenic reaction includes at least one of a corticosteroidand a leukotriene antagonist, Singular™.

[0025] The invention, in yet another form thereof, is directed to amethod of pretreating a patient prior to receiving desensitizing rapidimmunotherapy. The pretreatment method comprises, in combination, thesteps of administering to the patient prednisone and at least one of anH₁ histamine antagonist and an H₂ histamine antagonist, andadministering to the patient at least one of a corticosteroid and aleukotriene antagonist, Singular™.

[0026] One advantage of the present invention is that the protocol foradministering allergen to the patient according to a rapid immunotherapyprocedure can be successfully accomplished in less than 120 minutes, andmay be reduced further to less than 90 minutes (e.g., 75 minutes withsix injections spaced at 15 minute intervals), thereby improvingcompliance.

[0027] Another advantage of the present invention is that the rate ofsystemic reactions in patients can be significantly reduced relative toconventional rush immunotherapies by implementing a pretreatmentprotocol that administers to the patient a therapeutically effectiveamount of at least one composition which is effective in reducing thesensitivity of the patient to an asthma associated allergenic reactionthat may occur during and/or after reception of the desensitizing rapidimmunotherapy.

[0028] The exemplifications set out herein illustrate preferredembodiments of the invention, and such exemplifications are not to beconstrued as limiting the scope of the invention in any manner.

DETAILED DESCRIPTION OF THE INVENTION

[0029] A treatment method has been developed that is ordered towardsproviding therapeutic assistance to patients suffering from acute orimmediate hypersensitivity to various allergens. By way of background,immediate hypersensitivity (or anaphylactic response) is a form ofallergic reaction which develops very quickly, i.e., within seconds orminutes of exposure of the patient to the causative allergen. As usedherein, and conventionally understood, the term “allergen” relates to aspecific subclass of antigen which can trigger immediatehypersensitivity, which is mediated by IgE antibodies made by Blymphocytes.

[0030] In non-allergic patients, there is no IgE antibody of clinicalrelevance; however, in a person suffering with allergic diseases, IgEantibody mediates immediate hypersensitivity by sensitizing mast cellsthat are abundant in the skin, lymphoid organs, membranes of the eye,nose and mouth, and the respiratory tree and intestines. Mast cells havesurface receptors for IgE, and the IgE antibodies in allergy-sufferingpatients become bound to them. When the bound IgE is subsequentlycontacted by the appropriate allergen, the mast cell is caused todegranulate and to release various substances called bioactivemediators, such as histamine, into the surrounding tissue.

[0031] It is the biologic activity of the substances that is responsiblefor the clinical symptoms typical of immediate hypersensitivity, namely,contraction of smooth muscle in the airways or the intestines, thedilation of small blood vessels and the increase in their permeabilityto water and plasma proteins, the secretion of thick sticky mucus, and,in the skin, redness, swelling and the stimulation of nerve endings thatresults in itching or pain.

[0032] According to the present invention, a treatment method isprovided that encompasses a form of treatment conventionally known invarious equivalent alternative forms as rapid desensitization, rapidallergen immunotherapy, rapid allergen vaccination, and rapid or rushimmunotherapy. In broad terms, this procedure aims to advance anallergic patient to an immunizing or maintenance dose of extract (i.e.,allergen) by administering a series of injections (or via anothersuitable carrier) of increasing doses of the allergen at frequentintervals. If successful, the patient will exhibit an improvedresistance to the allergen, possibly even presenting a totalnon-reactivity to any subsequent allergen exposure. Conventional rush orrapid desensitization procedures typically take place over a period ofone to two days and up to several days and weeks.

[0033] According to the present invention, an accelerated rapidimmunotherapy protocol has been provided that administers the graduallyincreasing doses of allergen over a period of less than a few hours andyet achieves a rate of systemic reaction during or following treatmentthat is dramatically less than that demonstrated by conventionalallergen immunotherapies which take much longer.

[0034] In accordance with one embodiment of the present invention, amethod of treating a patient sensitive to an allergen includes aprotocol of administering to the patient a therapeutically effectiveamount of a composition comprising the allergen over a duration of lessthan about 120 minutes, and, more preferably, less than about 90minutes. The protocol is performed according to a rapid immunotherapyprotocol in which progressively increasing doses of the allergen areadministered at selected intervals, such as 10 to 20 minutes. Theprotocol is developed with a view towards enabling the patient to reachand/or advance to a maintenance dose within the allocated time frame.

[0035] In a preferred form, the treatment protocol employs a dilutionlevel for each allergen dosage that is within the range from betweenabout 1:150,000 to about 1:50,000 to between about 1:1500 to about1:500. In a more preferred form, the allergen doses are administered atabout 15 minute intervals according to the following dosage schedule:INTERVAL TIME (approx.) DOSAGE (approx.) 0 1:150,000 to 1:50,000  151:150,000 to 1:50,000  30 1:15,000 to 1:5,000  45 1:15,000 to 1:5,000 60 1:1500 to 1:500  75 1:1500 to 1:500 

[0036] Optional dosages of between about 1:150 to 1:50 may beadministered at 90 minutes and 105 minutes.

[0037] It should be understood that the manner of delivering theallergen dosages may encompass any suitable route (e.g., oral orinjection) and employ any pharmaceutically acceptable carrier as wellunderstood by those skilled in the art. Additionally, the times anddosage levels indicated above should be understood as forming guidelinesthat the skilled artisan may use to make adjustments thereto within thescope of the present invention. Other aspects of performing the rapidimmunotherapy procedure are well within the routine understanding andpractice of those skilled in the art. The ratios, volumes, and selectedallergen may be changed by the skilled artisan.

[0038] An examination and evaluation study was performed which conductedtwo separate half-day schedules for desensitizing and observing 311patients according to the present invention. All patients exhibitedpositive percutaneous skin tests to perennial and seasonal inhalantallergens. The targeted final dose ranged from about 0.1 cc to about 0.5cc of about a 1:1000 dilution of aqueous and glycerinated extractsmanufactured by ALK and Greer Laboratories. Most patients were thencontinued onto higher doses by resuming a conventional immunotherapyschedule. Patients ranged from 1½ to 68 years of age. Diagnoses includedallergic rhinitis (92%), asthma (51%), and chronic sinusitis (63%). Mostpatients also had associated headaches.

[0039] The following table illustrates the dosing schedule used in theforegoing study, using about 15 minute intervals for administering theallergen dosage. INTERVAL TIME (approx.) DOSAGE (approx.) AMOUNT (vol.)(approx.)  0 min. 1:100,000 0.025cc  15 min. 1:100,000  0.25 cc  30 min.1:10,000 0.025 cc  45 min. 1:10,000  0.25 cc  60 min. 1:1000 0.025 cc 75 min. 1:1000  0.25 cc  90 min. 1:100 0.025 cc 105 min. 1:100  0.1 cc

[0040] The dosages at 90 minutes and 105 minutes are optional. It shouldbe understood that the indicated volumetric quantities applicable toeach dosage may be suitably adjusted in a known manner to facilitate orotherwise adapt the immunotherapy protocol based upon the patientreaction or condition or in response to other factors well understood bythose skilled in the art. Dosage ratios may be varied within the scopeof the present invention. One reason the ratios may need to be changedmay be sensitivity of the patient to the allergen (e.g.,1:1,000,000,000, 1:1,000,000) to create an effective treatment for veryallergic patients.

[0041] The foregoing dosage schedule would be used in conjunction withadministering the allergen amount into one arm of the patient, forexample. A substantially identical schedule would be used to administeranother allergen amount into the other arm. Preferably, differentallergen types would be used to enable rapid desensitization involvingtwo different antigens within the same day. The two desensitizationregimens may be performed concurrently with one another (as in theforegoing study) or may be conducted in serial manner with one protocolfollowing the other, preferably within the same day.

[0042] Follow-up observations of the patients involved in the studyrevealed that eleven patients (3.5%) experienced a mild systemicreaction. Significantly, these documented systemic reactions occurredless frequently with the treatment protocol disclosed herein and used alower targeted final dose than previously described in the art. All ofthe patients responded to subcutaneous epinephrine and/or nebulizedalbuterol and were deemed fit to return home. None of the patientsexperienced true anaphylactic shock. These clinical results confirm thatmaintenance immunotherapy according to the present invention can bereached quickly, safely, effectively and with improved compliance.

[0043] In accordance with another embodiment of the present invention, apretreatment method is provided for use in combination with thetreatment protocol described above. The pretreatment method is performedon the patient prior to receiving rapid immunotherapy in the mannerdescribed above.

[0044] According to one aspect of the pretreatment method, there isprovided a protocol or regimen of administering to the patientprednisone (or any other suitable corticosteroid) and at least one of anH₁ histamine antagonist and an H₂ histamine antagonist. The H₁ histamineantagonist may be selected from the group comprising Claritin™(Loratadine), Seldane™ (Terfenadine), Zyrtec™ (Cetirizinehydrochloride), and Allegra™ (Fexafenadine hydrochloride), for example,while the H₂ histamine antagonist may be selected from the groupincluding Zantac™ (Ranitidine hydrochloride), Pepcid™ (Famotidine), andTagamet™ (Cimetidine), for example, where the associated generic drugname is indicated in parentheses. However, these individual drug typesshould not be considered in limitation of the present invention as itshould be apparent that other suitable anti-histamine orhistamine-blocking agents may be used. Additionally, any suitable mannerknown to those skilled in the art may be used to prepare and administerthis premedication regimen.

[0045] It was observed that the efficacy of the rapid immunotherapyprotocol (as measured in part by the number and degree of systemicreactions) tended to correlate roughly with the extent of pretreatmentthat was directed towards reducing or eliminating a sensitivity of thepatient to an asthma associated allergenic reaction, such as might occurduring and/or after the immunotherapy protocol. Accordingly, theforegoing pretreatment method is enhanced by administering to thepatient a therapeutically effective amount of at least one compositionwhich is effective in reducing the sensitivity of the patient to anasthma associated allergenic reaction. For example, the patient may beadministered a corticosteroid (oral or inhaled), and a leukotrienemedication such as Singular™, Accolade™, Zyflo™, or a combinationthereof. Additional asthma medications may also be used.

[0046] By controlling this vulnerability or susceptibility to anasthma-related allergenic reaction, it was found that the rate ofsystemic reactions was capable of being further reduced. Theadministration of this anti-asthma medication as part of thepretreatment protocol is preferably done in combination with the firstpremedication regimen discussed above. Notably, the invention does notuse antacids as part of the pretreatment protocol.

[0047] In the study mentioned above, 107 patients received premedicationwith prednisone (60 mg daily for adults and 2 mg/kg for children) and H₁antihistamine (Claritin™, Seldane™, Zyrtec™, or Allegra™), for threedays prior to receiving rapid desensitization. Additionally, 204patients received a premedication regimen of prednisone in combinationwith both H₁ and H₂ blockade (Zantac™, Pepcid™, or Tagamet™) andSingular™ with a dosage level of approximately 4 to 20 mg.

[0048] While this invention has been described as having a preferredmethodology and design, the present invention can be further modifiedwithin the spirit and scope of this disclosure. This application istherefore intended to cover any variations, uses, or adaptations of theinvention using its general principles. Further, this application isintended to cover such departures from the present disclosure as comewithin known or customary practice in the art to which this inventionpertains and which fall within the limits of the appended claims.

What is claimed is:
 1. A method of treating a patient sensitive to anallergen, comprising administering to said patient a therapeuticallyeffective desensitizing amount of a composition comprising said allergenover a duration of less than about 120 minutes.
 2. The method as recitedin claim 1, wherein the administration of said therapeutically effectivedesensitizing amount of said allergen composition being conductedaccording to a rapid immunotherapy protocol.
 3. The method as recited inclaim 1, further comprises a pretreatment protocol of administering tosaid patient a therapeutically effective amount of at least onecomposition effective in reducing a sensitivity of said patient to anasthma associated allergenic reaction.
 4. The method as recited in claim1, further comprises a pretreatment protocol of administering to saidpatient a corticosteroid and at least one of an H₁ histamine antagonistand an H₂ histamine antagonist.
 5. The method as recited in claim 4,wherein said pretreatment protocol further comprising administering tosaid patient at least one of a corticosteroid and a leukotrieneantagonist.
 6. The method as recited in claim 4, wherein saidpretreatment protocol further comprising administering to said patient atherapeutically effective amount of at least one composition effectivein reducing a sensitivity of said patient to an asthma associatedallergenic reaction.
 7. The method as recited in claim 1, wherein theadministration of said allergen amount further comprises administeringto said patient at selected intervals gradually increasing doses of saidallergen.
 8. The method as recited in claim 7, wherein each selectedinterval being about fifteen minutes.
 9. The method as recited in claim1, wherein the administration of said allergen amount further comprisesadministering to said patient at intervals of about fifteen minutesgradually increasing doses of said allergen.
 10. The method as recitedin claim 9, wherein the intervaled administration of allergen occurringin accordance with a dosing schedule consisting essentially of: (i) anamount having about a 1:100,000 allergen dilution, (ii) an amount havingabout a 1:100,000 allergen dilution, (iii) an amount having about a1:10,000 allergen dilution, (iv) an amount having about a 1:10,000allergen dilution, (v) an amount having about a 1:1000 allergendilution, and (vi) an amount having about a 1:1000 allergen dilution.11. The method as recited in claim 9, wherein each said allergen dosagehaving a dilution level within the range of from between about 1:150,000to about 1:50,000 to between about 1:1500 to about 1:500.
 12. The methodas recited in claim 11, further comprises a pretreatment protocol ofadministering to said patient a therapeutically effective amount of atleast one composition effective in reducing a sensitivity of saidpatient to an asthma associated allergenic reaction.
 13. The method asrecited in claim 11, further comprises a pretreatment protocol ofadministering to said patient prednisone and at least one of an H₁histamine antagonist and an H₂ histamine antagonist.
 14. The method asrecited in claim 13, wherein said pretreatment protocol furthercomprising administering to said patient at least one of acorticosteroid and a leukotriene antagonist.
 15. The method as recitedin claim 13, wherein said pretreatment protocol further comprisingadministering to said patient a therapeutically effective amount of atleast one composition effective in reducing a sensitivity of saidpatient to an asthma associated allergenic reaction.
 16. The method asrecited in claim 1, wherein said administration step being concurrentlyrepeated using another allergen.
 17. The method as recited in claim 1,wherein said administering step further includes the step ofadministering to said patient at intervals of about 15 minutes graduallyincreasing doses of said allergen each having a dilution level withinthe range of from between about 1:150,000 to about 1:50,000 to betweenabout 1:1500 to about 1:500.
 18. A method of treating a patientsensitive to an allergen, comprising a protocol of administering to saidpatient a series of gradually increasing doses of a compositioncomprising said allergen at selected intervals for a duration of lessthan about 120 minutes.
 19. The method as recited in claim 18, whereineach selected interval being about fifteen minutes.
 20. The method asrecited in claim 19, wherein the dilution level of allergen within eachdosage being within the range from between about 1:150,000 to about1:50,000 to between about 1:1500 to about 1:500.
 21. The method asrecited in claim 19, wherein said protocol being defined by a dosingschedule consisting essentially of: (i) an amount having about a1:100,000 allergen dilution, (ii) an amount having about a 1:100,000allergen dilution, (iii) an amount having about a 1:10,000 allergendilution, (iv) an amount having about a 1:10,000 allergen dilution, (v)an amount having about a 1:1000 allergen dilution, and (vi) an amounthaving about a 1:1000 allergen dilution.
 22. The method as recited inclaim 19, wherein the amount of said composition administered to saidpatient according to said protocol being therapeutically effective indesensitizing said patient against said allergen.
 23. The method asrecited in claim 19, wherein said allergen being selected from the groupconsisting of mold, mildew, dust, and dander.
 24. The method as recitedin claim 19, wherein said protocol being concurrently repeated usinganother allergen.
 25. The method as recited in claim 19, furthercomprises a pretreatment protocol of administering to said patient atherapeutically effective amount of at least one composition effectivein reducing a sensitivity of said patient to an asthma associatedallergenic reaction.
 26. The method as recited in claim 19, furthercomprises a pretreatment protocol of administering to said patientprednisone and at least one of an H₁ histamine antagonist and an H₂histamine antagonist.
 27. The method as recited in claim 26, whereinsaid prednisone being administered according to a daily dosage of about60mg/adult and 2mg/kg/child.
 28. The method as recited in claim 26,wherein said pretreatment protocol being carried out over about threedays.
 29. The method as recited in claim 26, wherein said H₁ histamineantagonist being selected from the group consisting of Claritin,Seldane, Zyrtec, and Allegra, and said H₂ histamine antagonist beingselected from the group consisting of Zantac, Pepcid, and Tagamet. 30.The method as recited in claim 26, wherein said pretreatment protocolfurther comprising administering to said patient at least one of acorticosteroid and leukotriene antagonist.
 31. The method as recited inclaim 26, wherein said pretreatment protocol further comprisingadministering to said patient a therapeutically effective amount of atleast one composition effective in reducing a sensitivity of saidpatient to an asthma associated allergenic reaction.
 32. A method oftreating a patient sensitive to an allergen, comprising a protocol ofadministering to said patient a series of gradually increasing doses ofa composition comprising said allergen at intervals of about 15 minutesfor a duration of less than about 120 minutes.
 33. The method as recitedin claim 32, wherein the dilution level of allergen within each dosagebeing within the range from between about 1:150,000 to about 1:50,000 tobetween about 1:1500 to about 1:500.a
 34. The method as recited in claim33, wherein said protocol being defined by a dosing schedule consistingessentially of: (i) an amount having about a 1:100,000 allergendilution, (ii) an amount having about a 1:100,000 allergen dilution,(iii) an amount having about a 1:10,000 allergen dilution, (iv) anamount having about a 1:10,000 allergen dilution, (v) an amount havingabout a 1:1000 allergen dilution, and (vi) an amount having about a1:1000 allergen dilution.
 35. The method as recited in claim 32, whereinthe amount of said composition administered to said patient according tosaid protocol being therapeutically effective in desensitizing saidpatient against said allergen.
 36. The method as recited in claim 32,further comprises a pretreatment protocol of administering to saidpatient a therapeutically effective amount of at least one compositioneffective in reducing a sensitivity of said patient to an asthmaassociated allergenic reaction.
 37. The method as recited in claim 32,further comprises a pretreatment protocol of administering to saidpatient prednisone and at least one of an H₁ histamine antagonist and anH₂ histamine antagonist.
 38. The method as recited in claim 37, whereinsaid pretreatment protocol further comprising administering to saidpatient at least one of a corticosteroid and leukotriene antagonist. 39.The method as recited in claim 37, wherein said pretreatment protocolfurther comprising administering to said patient a therapeuticallyeffective amount of at least one composition effective in reducing asensitivity of said patient to an asthma associated allergenic reaction.40. In the method for the treatment of an allergic condition by means ofdesensitization therapy by administering to a subject graduallyincreasing doses of a causative agent, the improvement wherein theadministration of said causative agent being conducted at intervals ofbetween about 10 to 20 minutes for a duration of less than about 120minutes using at each interval a dosage of said causative agent withinthe range of from between about 1:150,000 to about 1:50,000 to betweenabout 1:1500 to about 1:500.
 41. A method of treating a patientsensitive to an allergen, comprising a protocol of administering to saidpatient a series of gradually increasing doses of a compositioncomprising said allergen at selected intervals for a duration of lessthan about 120 minutes, said protocol being defined by a dosing scheduleconsisting essentially of: (i) an amount having about a 1:100,000allergen dilution, (ii) an amount having about a 1:100,000 allergendilution, (iii) an amount having about a 1:10,000 allergen dilution,(iv) an amount having about a 1:10,000 allergen dilution, (v) an amounthaving about a 1:1000 allergen dilution, and (vi) an amount having abouta 1:1000 allergen dilution.
 42. The method as recited in claim 41,wherein each selected interval being about fifteen minutes.
 43. Themethod as recited in claim 41, further comprises a pretreatment protocolof administering to said patient prednisone and at least one of an H1histamine antagonist and an H₂ histamine antagonist.
 44. The method asrecited in claim 43, wherein said H₁ histamine antagonist being selectedfrom the group consisting of Claritin, Seldane, Zyrtec, and Allegra, andsaid H₂ histamine antagonist being selected from the group consisting ofZantac, Pepcid, and Tagamet.
 45. The method as recited in claim 43,wherein said pretreatment protocol further comprising administering tosaid patient at least one of a corticosteroid and leukotrieneantagonist.
 46. A method of pretreating a patient prior to receivingdesensitizing rapid immunotherapy, comprising the steps of:administering to said patient prednisone and at least one of an H₁histamine antagonist and an H₂ histamine antagonist; and administeringto said patient a therapeutically effective amount of at least onecomposition effective in reducing the sensitivity of said patient to anasthma associated allergenic reaction occurrable during and/or afterreception of the desensitizing rapid immunotherapy.
 47. The method asrecited in claim 46, wherein said at least one composition administeredto reduce the sensitivity of said patient to an asthma associatedallergenic reaction comprising at least one of a corticosteroid andleukotriene antagonist.
 48. A method of pretreating a patient prior toreceiving desensitizing rapid immunotherapy, comprising the steps of:administering to said patient prednisone and at least one of an H₁histamine antagonist and an H₂ histamine antagonist; and administeringto said patient at least one of a corticosteroid and leukotrieneantagonist.